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Effects of tadalafil once daily (OaD) or on-demand (PRN) versus placebo on time to recovery
of erectile function (EF) in patients post bilateral nerve-sparing radical prostatectomy (nsRP)
Eur Urol Suppl 2014;13;e598 Print!
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Moncada I.1 , De Bethencourt F.R.2 , Turbi C.3 , Büttner H.4 , Henneges C.5 , Martinez Salamanca J.I. 6
1 Hospital
La Zarzuela, Dept. of Urology, Madrid, Spain, 2 Hospital La Paz, Dept. of Urology, Madrid, Spain, 3 Eli Lilly and Company, Medical
Department, Madrid, Spain, 4 Lilly Deutschland GmbH, Medical Department, Bad Homburg, Germany, 5 Lilly Deutschland GmbH, Dept. of
Global Statistical Sciences, Bad Homburg, Germany, 6 Hospital Universitario Puerta De Hierro-Majadahonda, Dept. of Urology, Madrid,
Spain
INTRODUCTION & OBJECTIVES: We report secondary data on time to EF recovery from a multicenter, randomized, double-blind, doubledummy, placebo-controlled trial (NCT01026818) evaluating the efficacy of tadalafil started early post-nsRP.
MATERIAL & METHODS: Patients ≤68 years who underwent nsRP for clinically localized prostate cancer (Gleason ≤7, normal preoperative
EF) were randomized post-nsRP 1:1:1 to 9-month treatment with tadalafil 5mg OaD, 20mg tadalafil PRN, or placebo, followed by 6-week
drug-free washout and 3-month open-label tadalafil OaD treatment. Secondary outcomes reported include Kaplan-Meier estimates of time
to EF recovery (IIEF-EF ≥22) during double-blind treatment (compared using Cox proportional hazard model adjusting for treatment, age,
and country).
RESULTS: 423 patients were randomized to tadalafil OaD (N=139), tadalafil PRN (N=143), and placebo (N=141); 114/122/155 completed
the double-blind phase. The raw proportion of patients achieving IIEF-EF ≥22 at some point during double-blind treatment with OaD, PRN,
and placebo was 29.5%, 23.9%, and 18.4% respectively. Double-blind treatment was too short to achieve EF recovery (IIEF-EF ≥22) in
>50% of patients; the median time to EF recovery was not estimable (censoring>70%). Time for 25% of patients to achieve EF recovery
(95%CI) was 5.8 (4.9-9.2) months for OaD, vs. 9.0 (5.5-9.2) and 9.3 (9.0-9.9) months for PRN and placebo, respectively (figure: KaplanMeier analysis). Showing a significant overall treatment effect (p=0.038), the probability for EF recovery was significantly higher for OaD
versus placebo (hazard ratio [HR], 95%CI: 1.9, 1.2-3.1; p=0.011). Tadalafil PRN showed a 1.5 HR for EF recovery (95%CI 0.9-2.5;
p=0.140) versus placebo. The HR for EF recovery was not significantly different based on patients’ age (<vs.≥65yrs: 1.3, 95%CI 0.9-2.0;
p=0.223).
CONCLUSIONS: Data suggest that the use of tadalafil OaD may accelerate EF recovery after nsRP.